Batch Record Reviewer II -- 295420 : QUALITY ASSURN ANCE at OQSIE
Fremont, CA
About the Job
This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met. The position performs logistical duties related to batch record review.
Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
Demonstrated proficiency in MS Office programs and associated computer programs.
Technical knowledge of manufacturing systems, methods and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes
Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
Demonstrated proficiency in MS Office programs and associated computer programs.
Technical knowledge of manufacturing systems, methods and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes